The present invention relates to a connector element for connecting tubes, cannulas and catheters to a second connector element. In particular, the present invention relates to a connector element that provides a sterile connection by remaining sealed with respect to the ambient atmosphere until the connection is made.
An important field of applications for connectors is the connection of multiple lengths of tubing, cannulas and catheters, as well as the connection of storage containers to medical working means, such as the connecting ports of a dialysis machine. To minimize any risk to the patient, high demands are placed on the strength and quality of the connectors as well as on maintaining the sterility of the connection to be established. It is important to ensure that there can be no contamination of the components before, during or after the operation of establishing the connection.
U.S. Pat. No. 3,986,508 describes generic connector elements provided with a part sealed before use, to thereby ensure that the portions of the connectors through which media flows remain sealed with respect to the atmosphere and are thus protected from contamination. The sealing parts are inserted into the connector elements to form a seal before use. Then the connector elements are sterilized in a partially assembled state in a heat sterilizer. Following this procedure, the connector elements are joined in such a way that the sealing parts are punctured by a mandrel provided in one of the connector elements, thereby opening a passage for the medium to be conveyed. In this process, the tip of the mandrel first punctures the inside of the sealing part of a connector element and then punctures the adjoining sealing part of the other connector element. One disadvantage of such an arrangement is that any contamination present on the side of the sealing part facing the mandrel could enter the area exposed to the medium once the sealing parts are punctured, and thus the contamination might enter the medium carried through the connector.
The present invention is directed to a connector element for connecting tubes, cannulas, catheters or other types of fluid lines that substantially obviates one or more of the problems due to limitations and disadvantages of the related art and that has a sealing part that includes a membrane.
Additional features and advantages of the invention will be set forth in the description which follows, and in part will be apparent from the description, or may be learned by practice of the invention. The objectives and other advantages of the invention will be realized and attained by the apparatus and method particularly pointed out in the written description and claims hereof, as well as the appended drawings.
To achieve these and other advantages and in accordance with the purpose of the invention, as embodied and broadly described, the invention is connector element that ensures a sterile connection between the connector element and a second connector element attached to the tube or device to be connected.
The connector element according to the invention has an opening element designed so that the sealing part does not come in contact with the area of the connector used as a conduit for conveying the medium, in either the closed or open position of the sealing part. According to the invention, the opening of the sealing part is not accomplished during the connection operation by contact with the areas or conduits through which the medium passes, but instead through opening elements which are designed and arranged to open the sealing part without allowing it to come in contact with the conduits, either when the sealing part is in the closed, open, or in any intermediary position. In this way, a sterile connection between the two connector elements is always achieved. A sterile connection is also obtained when contaminants might have reached the inside of the sealing part. For example, while establishing the connection, the sealing part is moved in an open position not by a part of the conduit conveying the medium, but instead is opened by a separate opening element, to preclude any contact between the parts of the connector coming in contact with the medium and the sealing part that may be contaminated.
It is especially advantageous if the sealing part includes a base body with a membrane extending over the cross section of the base body. The sealing part can be designed as a cap which is movable relative to the areas for conveying the medium, and its membrane must be opened to allow flow of the fluid during the connection. According to the present invention, the membrane of each connector element is opened by an opening element of the other connector element.
In another preferred embodiment of the present invention, the base body of the sealing part is a cylindrical shell and the membrane is arranged on one end of the base body. The sealing part is advantageously used in such a way that the end area of the base body provided with the membrane of one connection element is oriented away from the xe2x80x9cconnection sidexe2x80x9d, which is the side of the connector element where the second connector element is inserted. This offers the advantage that a significant portion of the base body protects the membrane from contact, because the membrane is set back from the connection side end portion of the connector element by approximately the length of the base body. It is thus possible to prevent inadvertent contact between the membrane and the opening element of the second connector element.
In a further embodiment of the present invention, the membrane has a straight or cross-shaped slit for the purpose of facilitating opening of the sealing part. This slit is such that the areas for conveying the medium are sealed when the connector elements are disconnected, and only when the connector elements are actuated or joined is the slit opened, to ultimately permit flow through the connector.
According to a preferred embodiment of the present invention, the membrane is a silicone membrane. Such a membrane will close and form a sufficient seal even after slitting, while on the other hand it can easily be folded open and penetrated.
According to another preferred embodiment of the present invention, the conduit for conveying a flowing medium is defined by an inner socket connector. The socket connector borders the parts of the connector element coming in contact with the media, and can be inserted in a fluid-tight manner into the socket connector of another connector element when the connection is established. It is especially advantageous to form the opening element as an outer socket connector, also surrounding the area for conveying the medium.
The area or conduit for conveying the medium and the opening element may be formed by a concentric arrangement of socket connectors, with the outer socket connector which forms the opening element projecting slightly beyond the inner socket connector bordering the area for conveying the medium. This yields a relatively simple arrangement, with the outer of the concentric tubes forming the opening element and the inner concentric tube bordering the area for conveying the flowing medium. According to the present invention, the required opening of the sealing part is achieved by the opening elements, because these are arranged on the outside of the inner socket connectors thereby effecting an opening of the moving sealing part before it comes in contact with the areas exposed to the media. It is also advantageous if the outer socket connector of the opening element projects slightly above the inner socket connector of the area for conveying the medium, or even terminates it. It is essential for the sealing part to be guided or opened in such a way as to prevent contact with the areas for conveying the medium in all stages of movement of the sealing part.
In yet another embodiment of the present invention, the connector element has a housing, with the area for conveying the medium as well as the opening element being accommodated in the housing. It is especially advantageous if an annular gap is formed between the housing and the opening element to accommodate the sealing part when it is moved. Accordingly, the sealing part is guided between the housing and the wall of the opening element while the connection is made, and is moved by the opening element of the second connector element into-a position which causes the sealing part to be opened. At the same time, or subsequently, the sealing part of the second connector element may also be moved back in a corresponding annular gap of the second connector element in an equivalent manner, so that ultimately the areas for conveying the medium of the two connector elements can come in contact with one another without ever being in contact with the inside or outside of the sealing parts.
According to a further preferred embodiment of the present invention, the sealing part can be secured in the housing by a lock. This makes it possible to manufacture the connectors and the sealing parts in two separate operations, to insert the sealing parts into the housing after their manufacture and to secure them in the desired position using the lock. The lock may be constituted of a projection extending away from the housing and a matching recess in the sealing part.
In yet another embodiment of the present invention, the area for conveying the medium can be sealed by a shut-off element. The shut-off element causes fluid-tight sealing of the areas for conveying the medium and can be opened by appropriate penetration elements, when needed, while making the connection. For example, it is thereby possible for the conduit to be filled with liquid from a storage container, up to the shut-off element, before the connection is made.
It is especially advantageous if a penetration body movable relative to the shut-off element is provided and is arranged so that the shut off element can be opened by the penetration body. The penetration body can thus be moved by one of the connector elements during the making of the connection, in such a manner that first the shut-off element of one of the two connector elements to be joined is opened, and then the shut-off element of the other connector element is penetrated, thus permitting flow through the connector.
In another embodiment of the present invention, the area for conveying the medium is formed by an inner socket connector, and the penetration body is arranged in the inner socket connector. Such a connector element is assembled by first inserting the penetration body into the inner socket connector in a suitable position and then inserting the sealing parts. The penetration body may include a projection which can be connected with the inner socket connector of the second connector element. When the projection of the penetration body of one connector element comes in contact with the other connector element while the connection is being established, the penetration body is moved as the connection operation continues, thereby opening the shut-off element.
According to yet another preferred embodiment of the present invention, the shut-off element is designed as an injection molded membrane, preferably made of polypropylene. Due to the use of injection molded membranes, the corresponding areas of the connector elements are hermetically sealed, free of dead space and made of a single material. A particular advantage of using injection molded membranes is the fact that these can be produced together with the other components of the connector element by injection molding in a single operation, thus eliminating subsequent welding of film membranes or subsequent welding or snap assembly of individual components fitted with membranes.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the invention as claimed.